|
(11) | EP 2 779 940 B3 |
| (12) | NEW EUROPEAN PATENT SPECIFICATION |
| After limitation procedure (B3-1) |
|
|
| (54) |
DEVICE FOR AORTIC BRANCHED VESSEL REPAIR VORRICHTUNG ZUR REPARATUR EINES VERZWEIGTEN AORTENGEFÄSSES DISPOSITIF POUR LA RÉPARATION DE VAISSEAU BRANCHÉ AORTIQUE |
|
|
|||||||||||||||||||||||||||||||||||
BACKGROUND OF THE INVENTION
[0001] Aortic aneurysms are life-threatening conditions. Surgical interventions used to treat aortic aneurysms include endovascular repair by transluminal placement of one or more endografts across the longitudinal extent of the lesion. The endograft is placed in the aorta with the intention of bridging the aneurysmal sac to exclude it from the high-pressure of aortic blood flow, which can permit remodeling of the aortic wall in and around the aneurysm site. In certain regionsofthe aorta accurate placement of the endograft is critical to maintain blood flow to vessels branching from the aorta to minimize compromised blood flow to organs. For example, currently, if aortic devices are placed within the aortic arch in a manner that offsets the aperture for the left carotid artery, the artery can be occluded, which can result in ischemia to the brain. Most surgical methods of treating aneurysms at or near the aortic arch generally involve sternotomy or thoracotomy and may require cardiopulmonary bypass, often resulting in high morbidity rates. Thus, there is a need to develop new and useful devices and methods of treating aortic aneurysms by endovascular methods.
SUMMARY OF THE INVENTION
[0003] The present invention discloses an aortic graft assembly according to claim 1. There is described vascular repair systems, delivery systems and methods of using the delivery systems and its components to treat aortic vascular damage, in particular, vascular damage associated with aortic disease, such as, aneurysms, penetrating atherosclerotic ulcers and dissection.
[0004] In an embodiment, the invention is an aortic graft assembly that includes a tubular aortic component having a proximal end and a distal end connected by a wall of the tubular aortic component, the wall defining a wall aperture that is between the proximal and distal ends. The aperture has a proximal end that extends perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis. A tunnel graft is connected to the wall of the tubular aortic component and extends from the wall aperture toward the proximal end of the tubular aortic component. The tunnel graft has a proximal end and a distal end, the distal end being at the wall aperture of the tubular aortic component. A proximal stent abuts the proximal end of the aperture, and a distal stent abuts a distal end of the aperture.
[0005] In yet another embodiment, the invention is an aortic graft assembly, comprising a tubular aortic component that includes a proximal end and a distal end connected by a wall of the tubular aortic component, the wall defining a wall aperture that is between the proximal and distal ends, the wall aperture having a proximal end and a distal end, the proximal end of the wall aperture extending perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis; a tunnel graft connected to the wall of the tubular aortic component and extending from the wall aperture toward the proximal end of the tubular aortic component, the tunnel graft having a proximal end and a distal end, the distal end being at the wall aperture of the tubular aortic component; a proximal stent that supports the proximal end of the tubular aortic component; a distal stent that supports the distal end of the tubular aortic component; a clasping stent at the proximal end of the tubular aortic component, the clasping stent including at least two exposed proximal apices proximate to the proximal end of tubular component and attached to an interior wall of the tubular aortic component; and a crown stent between the clasping stent and the proximal end of the tubular aortic component, the crown stent attached to an interior surface of the tubular aortic component.
[0006] In a further embodiment, the invention is an aortic graft assembly, comprising a tubular aortic component that includes a proximal end and a distal end connected by a wall of the tubular aortic component, the wall defining a wall aperture that is between the proximal and distal ends, the wall aperture having a proximal end and a distal end, the proximal end of the wall aperture extending perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis; a tunnel graft connected to the wall of the tubular aortic component and extending from the wall aperture toward the proximal end of the tubular aortic component, the tunnel graft having a proximal end and a distal end, the distal end being at the wall aperture of the tubular aortic component; a proximal stent that abuts the proximal end of the tubular aortic component; a distal stent that supports the distal end of the tubular aortic component; an abutting distal stent that includes at least one proximal apex that abut the distal end of the wall aperture; a clasping stent at the proximal end of the tubular aortic component, the clasping stent including at least two exposed proximal apices proximate to the proximal end of tubular component and attached to an interior wall of the tubular aortic component; and a crown stent between the clasping stent and the proximal end of the tubular aortic component, the crown stent attached to an interior surface of the tubular aortic component.
[0007] There is described a method for implanting a prosthesis, including delivering a tubular aortic component defining a wall aperture through an aorta of a patient to an aneurysm site of the patient, the tubular aortic component being radially and releasably constrained by a distal clasp at a distal end of an outer control tube of a delivery device, and releasably attached by a retention component to a proximal clasp at the outer control tube proximal to the proximal clasp, the tubular aortic componentfurther supported by a control catheter of the delivery device extending within the outer control tube. The wall aperture is aligned over at least one vessel ostium at the aneurysm site of the patient. The outer tube is retracted, thereby releasing the tubular aortic component from the distal and proximal clasps, thereby deploying the tubular aortic component at the aneurysm site.
[0008] There is also described a method for implanting a prosthesis, comprising the steps of delivering a tubular aortic component defining a wall aperture through an aorta to an aneurysm site of a patient, the tubular aortic component being radially and releasably constrained by a distal clasp at a distal end of an outer control tube of a delivery device, and releasably attached by a retention component to a proximal clasp at the outer control tube proximal to the proximal clasp, the tubular aortic component further supported by a control catheter of the delivery device extending within the outer control tube; aligning the wall aperture over at least one vessel ostium at the aneurysm site of the patient; retracting the outer control tube, thereby releasing the tubular aortic componentfrom the distal and proximal clasps, thereby deploying the tubular aortic component at the aneurysm site in the patient, wherein at least one supporting wire extends from the control tube, said supporting wire extending through a suture loop inside the proximal end of the tubular aortic component to thereby prevent collapse of the proximal end of the tubular component during deployment. The method can further include the step of partially retracting an inner sheath from around the tubular aortic component, whereby the supporting wire at least partially restricts longitudinal movement of the proximal end of the tubular aortic component until the proximal end of the tubular aortic component is secure within the aorta, to thereby prevent collapse of the proximal end of the tubular aortic component at an inferior portion of the aorta, wherein the inner sheath is releasably secured to a distal end within a cavity defined by a proximal end of the nose cone, wherein the steps of the method include partially retracting an inner sheath from around the tubular aortic component to release the distal end of the inner sheath from the nose cone and thereby cause partial deployment of the tubular aortic component; partially retracting the control catheter to thereby release the clasping stentfrom the distal apex clasp and the retention component from the proximal clasp; further retracting the control catheter to at least partially retract the nose cone to within the tubular aortic component while retaining the suture loops on the supporting wires; advancing the tubular aortic component to a final position in the aorta of the patient spanning the aneurysm; fully retracting the inner sheath from the tubular aortic component; and fully retracting the nose cone and supporting wires to release the suture loops from the supporting wires, thereby fully deploying the tubular aortic component within the aorta of the patient.
[0009] A stent defining the aperture permits blood flow into the ostium of the target vessel, unlike other systems that rely on a narrowing or dog-bone shape of the body of the tubular aortic component of an aortic graft system to permit blood flow outside and around the tubular graft component if the surgeon is unable to align the aperture with the ostium of the target vessel.
[0010] The aortic graft assembly of the invention does not require precise radial or longitudinal alignment in the aorta and permits approximate alignment, which is beneficial in reducing the manipulation of the aortic arch and resulting stroke in the patient. The claimed systems can be fully deployed before the surgeon completes the endovascular procedure by deployment of the first tunnel or second tunnel graft, unlike current aortic components that are in a "dogbone" configuration to guard against unintentional obstruction of the target ostium. The delivery device employed with the graft assembly aids in proper alignment of the assembly in the aorta by, for example, use of a curved guidewire catheter, proximal clasp and distal clasp.
[0011] The aortic assembly systems of the invention and the described methods can be employed to treat aortic aneurysms, such as aortic aneurysms at, near or around the arch of the aorta, or branches from the abdominal aorta (e.g., celiac artery, superior mesenteric artery and renal arteries). The aortic assembly systems of the invention have a relatively large aperture tapered into a tunnel graft that provides the surgeon with a relatively large margin of error in placement of the system, facilitates canulation and permits alignment of a single aperture for at least one blood vessel. Aortic assembly systems of the invention that include a tunnel graft having one aperture extending proximally with two openings permit for easy alignment in the aorta, particularly in regions of the aorta that branch to peripheral and major vessels. The size of the aperture allows blood to flow to target vessels during the procedure. The aortic graft assembly of the invention generally does not restrict blood flow acutely or chronically, in part, because of a relatively large diameter of the tunnel graft and the stent or stents supporting the tunnel graft.
[0012] Barbs in the interior of the tunnel grafts of the branched graft assembly have the advantage of securing connection of the tubular component to the tunnel graft. The telescoping ability of the graft assembly systems of the invention, for example, the length and different configurations of the tunnel graft, allow the tubular component to be positioned in-situ to ensure maximum use of a "landing zone" inside the target vessel. A relatively long tunnel length can ensure adequate overlap with the tubular component into the tunnel grafts to ensure a sufficient seal.
[0013] The delivery device of the invention also has the advantage of allowing the proximal end of the stent graft to be aligned perpendicular to the center line axis of the "landing zone." This is of key concern when the landing zone is in Zone 0 (FIGs. 15, 16, 17) of the ascending aorta. When landing in this area much care must be taken to avoid accidental coverage of the coronary arteries, typically the left coronary artery.
[0014] Thus, the aortic graft assembly, delivery systems of the invention can be used to treat various aortic pathologies, including aortic aneurysms, penetrating atherosclerotic ulcers, dissections and, therefore, avoid complications and death consequent to life-threatening vascular conditions.
BRIEF DESCRIPTION OF THE FIGURES
[0015]
FIGs. 1A, 1B and 1C represent an embodiment of an aortic assembly system of the invention.
FIGs. 2A and 3A represent cross sectional views of the aortic assembly system of the invention, shown in FIG. 1A, taken along line 2A.
FIGs. 2B and 3B represent a longitudinal view of
FIGs. 2A and 3A of an aortic assembly system of the invention.
FIGs. 4A and 4B represent embodiments of an aortic assembly system of the invention, taken from views 4A and 4B of FIGs. 2A and 2B.
FIG. 5 is a perspective view into the proximal end of an aortic graft assembly.
FIG. 6 represents another embodiment of an aortic assembly system of the invention.
FIGs. 7A and 8A represent additional embodiments of an aortic assembly system of the invention.
FIGs. 7B and 8B represent additional embodiments of an aortic assembly system of the invention taken along lines 7B and 8B of FIGs. 7A and 8A, respectively.
FIGs. 9A and 10A represent additional embodiments of an aortic assembly system of the invention.
FIGs. 9B and 10B represent further embodiments of an aortic assembly system of the invention taken along lines 9B and 10B of FIGs. 10A and 10B, respectively.
FIG. 11 is a perspective view of one embodiment of an aortic assembly system of the invention mounted on one embodiment of a delivery system of the invention.
FIG. 12 represents placement of an embodiment of an aortic graft assembly of the invention in the ascending aorta, aortic arch and a portion of the descending aorta of a subject.
FIG. 13 represents zones (0, 1, 2, 3 and 4) of the aorta and major vessels branching from the aorta (prior art).
FIG. 14 represents zones (0, 1, 2, 3 and 4) of the aorta, an aortic aneurysm, a right carotid artery to left carotid artery bypass, a left carotid artery to left subclavian artery bypass and ligation of the left carotid and left subclavian arteries (prior art).
FIG. 15 represents zones (0, 1, 2, 3 and 4) of the aorta, an aortic aneurysm, a left carotid artery to left subclavian artery bypass and ligation of the left subclavian artery (prior art).
FIGs. 16A-16F are a representation of one embodiment of an aortic assembly system of the invention of one embodiment of a delivery system of the invention.
FIGs. 17A-17C are side, cross-sectional and perspective views of one embodiment of the invention, respectively.
FIG. 18 is a perspective view of a nose cone, and inner sheath tucked into a proximal cavity of the nose cone of one embodiment of the invention.
FIGs. 19A and 19B represent alternative embodiments of an inner sheath of an embodiment of a delivery system of the invention.
FIG. 20 represents an alternative embodiment of an inner sheath of an embodiment of a delivery system of the invention.
FIGs. 21A and 21B represent additional alternative embodiments of an inner sheath of an embodiment of a delivery system of the invention.
FIG. 22 represents an embodiment of a portion of a delivery system employed by the invention.
FIGs. 23A-23D represent additional views of an aortic assembly system and branch graft of the invention.
FIGs. 24A-24E represent method steps of one embodiment of a method.
FIGs. 25A and 25B represent alternative embodiments of an inner sheath component of one embodiment of the invention.
FIGs. 26A-26C represent method steps of one embodiment of an alternative method.
DETAILED DESCRIPTION OF THE INVENTION
[0016] The features and other details of the invention, either as steps or as combinations of parts of the invention will now be more particularly described and pointed out in the claims. It will be understood that the particular embodiments of the invention are shown by way of illustration and not as limitations of the invention. The principle features of this invention can be employed in various embodiments without departing from the scope of the invention.
[0017] "Proximal" means, when reference is made to a delivery system or a component of a delivery system, such as an apex clasp and a nose cone, closest to the clinician using device. Likewise, "distal" means, when reference is made to a delivery system or a component of a delivery system, such as an apex clasp and a nose cone, away from the clinician using the device.
[0018] When reference is made to a prosthesis to be delivered, such as an aortic graft assembly, tubular aortic component, tunnel graft, branch graft and stent, the word "proximal" means that portion of the prosthesis or component of the prosthesis that is towards the heart of the patient and "distal" means that portion of the prosthesis or component of the prosthesis that is away from the heart of the patient. For clarity, the word "proximate" means close to as opposed to "proximal" or "distal."
[0019] Aortic graft assemblies of the invention can be implanted, for example, by transfemoral access. Tubular branch components can be implanted, for example, by supraaortic vessel access (e.g., brachial artery), or by transfemoral or transapical access.
[0020] The invention is generally directed to an aortic graft assembly. There is described a method for deploying the aortic graft assembly.There is also described a method of implanting at least one tubular branch graft into a patient and the aortic graft assembly. In one embodiment of the aortic graft assembly of the invention, represented in FIGs. 1A through FIG. 1C, aortic graft assembly 10 includes tubular aortic component 12 having proximal end 14 and distal end 16 connected by wall 18. Wall 18 defines wall aperture 20 that is between proximal end 14 and distal end 16. Wall aperture 20 has proximal end 22 that extends perpendicular to a major longitudinal axis 24 of tubular aortic component 12 when viewed orthogonally to major longitudinal axis 24. Wall aperture 20 also defines distal end 26 of wall aperture 20.
[0021] Tunnel graft 28, shown, for example, in FIGs. 2A, 2B, 3A, 3B, 4A and 4B is connected to wall 18 of tubular aortic component 12 and extends from wall aperture 20 toward proximal end 14 of the tubular aortic component 12. Tunnel graft 28 includes proximal end 30 and distal end 32. Distal end 32 of tunnel graft 28 is at wall aperture 20 of tubular aortic component 12.
[0022] Referring back to FIGs. 1A-1C, proximal stent 34 supports proximal end 14 of tubular aortic component 12. Distal stent 36 supports distal end 16 of tubular aortic component 12. Similarly, distal stent 36 can be attached to an interior wall to tubular aortic component 12.
[0023] Optionally, radiopaque markers 38 are located along a line parallel to major longitudinal axis 24 of tubular aortic component 12. In one embodiment, radiopaque marker 38 is at a proximal apex of wall aperture distal stent 50 abutting wall aperture 20. Another radiopaque marker is at a distal apex 48 of proximal stent 34. Further, radiopaque marker 38 is at least one of proximal end 14 and distal end 16 of tubular aortic component 12. Also optionally, radiopaque markers 40 extend about the circumference of wall aperture 20 at tubular aortic component 12. Radiopaque markers 38, 40 can be made of any suitable material such as platinum, iridium, gold, etc. Examples of radiopaque markers are described in the U.S. Patent No.: 8,062,345 and U.S. Published Patent Application No.: US 2010/0030255.
[0024] Proximal stent 34 in one embodiment, shown in FIGs. 1A, 1B and 1C, includes proximal apices 46 and distal apices 48. In one embodiment, at least a portion of distal apices 48 abut proximal end 22 of wall aperture 20. Wall aperture distal stent 50 includes proximal apices 52 and distal apices 54, a portion of proximal apices 52 of wall aperture distal stent 50 abut distal end 26 of wall aperture 20. Clasping stent 56 at proximal end 14 of tubular aortic component 12 includes at least two exposed proximal apices 58 proximate to proximate end 14 of tubular aortic component 12. In one embodiment, clasping stent 56 is attached to an interior wall of tubular aortic component 12.
[0025] Crown stent 60 is located between clasping stent 56 and proximal end 14 of tubular aortic component 12. As can be seen in FIG. 5, at least two support wire sutures 62 are located within tubular aortic component 12 at proximal end 14 of tubular aortic component 12, distal to proximal apices 58 of clasping stent 56. Support wires sutures 62 are separated by at least one distal apex 61 of clasping stent 56. In one embodiment, proximal apices 59 of crown stent 60 are blunted, as shown in FIG. 1A. Crown stent 60 and clasping stent 56 can be nested, as shown in FIG. 1A. Crown stent 60 and clasping stent 56 are attached to interior wall 76 of tubular aortic component 12.
[0026] At least one stent 64 is located at tubular aortic component 12 between proximal stent 34 and distal stent 36. At least a portion of stents 64 include proximal apices 66 and distal apices 68 connected by struts 70. At least one partial stent 72 is located at tubular aortic component 12 between stents 34, 50 abutting proximal 22 and distal 26 ends of wall aperture 20, respectively, as shown in FIGs. 1B and 1C.
[0027] Stents employed in the invention are constructed of a suitable material. In one embodiment, the stents employed by the invention include a suitable shape memory alloy, such as nitinol. Further description of suitable materials for construction of stents for use in the invention can be found in U.S. Patent Nos.: 7,763,063 and 8,062,345.
[0028] In one embodiment, the arc length of proximal end 22 of wall aperture 20 is equal to or less than one-half the circumference of tubular aortic component 12. Examples of suitable arc lengths of proximal end 22 of wall aperture 20 include arc lengths equal to one member selected from the group consisting of about 6 mm, about 8 mm, about 10 mm, about 12 mm or about 14 mm. In one embodiment, a longitudinal length of wall aperture 20 is equal to or less than about 90 mm. In another embodiment, the longitudinal length of wall aperture 20 is equal to or greater than about 14 mm.
[0029] Referring to FIGs. 2A, 2B, 3A and 3B, the distance between proximal end 22 of wall aperture 20 and proximal end 14 of tubular aortic component 12 can be in a range of between about 10 mm and about 80 mm. In a typical embodiment, the distance between proximal end 22 of wall aperture 20 and proximal end 14 of tubular aortic component 12 is one member selected from the group consisting of about 20 mm, about 40 mm, about 60 mm, about 80 mm or about 90 mm. In one embodiment, the distance between proximal end 22 of wall aperture 20 and proximal end 12 of tubular aortic component 12 is about 40 mm, as shown in FIGs. 2A and 2B. In another embodiment, the distance between proximal end 22 of wall aperture 20 and proximal end 14 of tubular aortic component 12 is about 60 mm, as shown in FIGs. 3A and 3B.
[0030] In one embodiment, shown in FIG. 1A, retention component 78 is located at tubular aortic component 12 distal to wall aperture 20 and within tubular aortic component 12 (only external portion of retention component 78 is shown in FIG. 1A). In one embodiment, retention component is a suture loop. In another embodiment, retention component 78 is at least one of a magnet or a stent apex. In still another embodiment, retention component 78 is radiopaque. In one embodiment, retention component 78 is ata proximal apex 52 of stent 50 abutting distal end 26 of wall aperture 20.
[0031] In another embodiment, shown in FIG. 6, circumferential stent 80 is located at tubular aortic component 12 and surrounds wall aperture 20. In one embodiment, a circumferential stent 80 surrounding wall aperture 20 defines, at least in part, wall aperture 20. In one embodiment, the diameter of proximal end 14 of tubular aortic component 12 is greater than the diameter of distal end 16 of tubular aortic component 12, as shown in FIG. 1B.
[0032] In one embodiment, shown in FIGs. 7A, 8A, 9A and 10A, the interface between tubular aortic component 12 and wall aperture 20, when viewed orthogonally to major longitudinal axis 24 of tubular aortic component 12 is a polygon, such as is shown in the referenced figures, a polygon having four sides. In various embodiments, the polygon can be a square, a rectangle, a parallelogram, or a rhombus (not shown).
[0033] In a specific embodiment, inferior portion 83 is on one side of tubular aortic component 12 opposite wall aperture 20 and is essentially parallel to major longitudinal axis 24 of tubular aortic component 12, shown in FIG. 1B. Exposed apices 58 of clasping stent 56, when collapsed will cause at least partial collapse of proximal end 14 of tubular aortic component 12 at clasping stent 56, as can be seen in FIG. 11. At least one of support wire sutures 62 are at inferior portion 83 within tubular aortic component 12. In a specific embodiment, support wire sutures 62 are at apices of clasping stent 56. Preferably, support wire sutures 62 are separated by at least one proximal apex of clasping stent.
[0034] In one embodiment, distal end 32 of tunnel graft 28 has a diameter greater than that of proximal end 30 of tunnel graft 28, as can be seen in FIGs. 2A and 3A. In another embodiment, proximal end 30 of tunnel graft 28 is between the most proximal edge of proximal end 14 of tubular aortic component 12 and proximal end 22 of wall aperture 20, as shown in FIGs. 2A, 2B, 3A, 3B, 4A and 4B. As shown in FIGs. 4A and 4B, tunnel graft 28 is secured to an interior wall of tubular aortic component 12 by a suitable means, such as by sutures 29.
[0035] As can be seen in FIGs. 1B, 1C, 2A, 2B, 3A and 3B, tunnel graft 28 includes open portion 84 at wall aperture 20. Tubular portion 86 extends proximally from open portion 84, as shown in FIGs. 2A, 2B, 3A and 3B. In one embodiment, tubular portion includes stents 88, 90 at each of a proximal 92 and distal end 94 of tubular portion 86, as shown in FIGs. 2B and 3B. Preferably, stents 88, 90 at proximal 92 and distal 94 ends of tubular portion 86 includes proximal and distal apices connected by struts. Preferably, stent 88 at proximal end 92 of tubular portion 86 includes at least one barb 96 (FIG. 2B). In another embodiment shown in FIG. 3B, barbs 96 extend for distal apices of stent 98 of tubular portion 86. Optionally, tubular portion 86 further includes at least one stent 98 between stents 88, 90 at proximal 92 and distal 94 ends, respectively, of tubular portion 86. Preferably, at least one of stents 98 between stents 88, 90 at proximal end 92 and distal end 94 includes at least one barb. Most preferably, stents of tubular portion 86 include nitinol.
[0036] As can also be seen in FIGs. 2A and 2B and 3A and 3B, 4A and 4B, distal end 94 of tubular portion 86 is generally conical, whereby distal end 94 of tubular portion 86 extends from proximal end 92 of tunnel graft 28 to proximal end 22 of wall aperture 20, as a continuum or, optionally, at a seam, not shown. In one embodiment, a maximum diameter of proximal end 92 of tunnel graft 28 is equal to or less than the diameter of distal end 94 of tubular portion 86. Examples of suitable maximum diameters of proximal end 30 of tunnel graft 28 include, for example, diameters equal to or greater than a diameter selected from the group consisting of about 6 mm, about 8 mm, about 10 mm, about 12 mm or about 14 mm.
[0037] Preferably, tubular portion 86 has a major longitudinal axis that is parallel to major longitudinal axis 24 of tubular aortic component 12. Proximal end 92 of tubular portion 86 is distal to the most proximal edge of proximal end 14 of tubular aortic component 12. In one embodiment, not shown, proximal end 92 of tubular portion 86 is coterminous with the most proximal edge of proximal end 14 of tubular aortic component 12 or, alternatively, as shown in FIGs. 2A and 2B and 3A and 3B, 4A and 4B, is distal to proximal end 14 of tubular aortic component 12. In another embodiment, tubular portion 86 has a major axis at an angle A 81 relative to major longitudinal axis 24 of tubular aortic component 12, as shown in FIG. 9A. In one embodiment, the angle is in the range of at least one of between about 0° and about 90°, such as 10°, 20°, 30°, 45°, 60°, and 90° C.
[0038] Further, as shown in FIGs. 9A and 9B, proximal end 92 of tubular portion 86 has geometric center 150 that is distinct from a geometric center 152 of tubular aortic component 12, wherein line 154 defined by geometric center 150 of proximal end 92 of tubular portion 86 and geometric center 152 of tubular aortic component 12 in a plane defined by proximal end 92 of tubular portion 86, taken along line 9 B of FIG. 9A, is at a positive angle B from line 156 defined by geometric center 152 of tubular aortic component 12 and point 158 along centerline 160 bisecting wall aperture 20 and parallel to major longitudinal axis 24 (FIG. 1A) of tubular aortic component 12, point 158 being in the same plane as the geometric centers 150, 152 of proximal end 92 of tubular portion 86 and tubular aortic component 12, respectively. Examples of suitable positive angles B can be at least one member selected for the group consisting of ±10°, ±20°, ±30°, ±45°, ±60°, ±90°, ±120°, ±135°, ±160°, ±170° and 180°.
[0039] In one embodiment, at least one radiopaque marker 99 is located at at least one of proximal end 92 of tunnel graft 28 and distal end 94 of tubular portion 86 of tunnel graft 28, as shown in FIGs. 2B, 3B and 4B. Another embodiment includes tubular portion 100 and further includes second tubular portion 102 of tunnel graft 28 extending proximal to open portion 84 of the tunnel graft 28, wherein second tubular portion 102 has distal end 104 and proximal end 106 as shown in FIGs. 7A, 7B, 8A and 8B. In one embodiment, not shown, second tubular portion 102 is of unequal length to that of first tubular portion 100. In another embodiment, shown in FIGS. 7A and 7B, second tubular portion 102 is parallel to first tubular portion 100. First tubular portion 100 and second tubular portion 102 are each a distinct, and integrally complete tubular portion. In another embodiment, shown in FIGs. 8A and 8B, tubular portions share common wall of a first graft material 108 that partition a conduit of the second graft material 110. In this embodiment, first 108 and second 110 graft materials define, at least in part, first tubular portion 100 and second tubular portion 102. As shown in FIGs. 10A and 10B, tubular portions 112 and 114 extend away from each other and proximally from open portion 84.
[0040] In still another embodiment, shown in FIGs. 2A, 2B, 3A, 3B, 4A and 4B, proximal end 92 of tunnel graft 28 has a diameter in a range between about 5 mm and about 10 mm, or between about 5 mm and about 15 mm, or between about 8 mm and about 15 mm. Generally, tubular portion 86 has a length in a range of between about 20 mm and about 60 mm, or between about 20 mm and about 100 mm. Most commonly, tubular portion 86 has a length in a range between about 30 and 50 mm. Preferably, proximal end 92 of tunnel graft 28 is within at least about 5 mm, about 10 mm, and about 15 mm or about 20 mm of proximal end 14 of tubular aortic component 12.
[0041] FIG. 12 shows one embodiment of aortic graft assembly 10 of the invention fully deployed within aorta 117 of a patient. FIGs. 13-15 show various stages of an aortic bypass operation (prior art).
[0042] As shown, in FIGs.16A-16F, aortic graft assembly 200 (FIG. 16A) includes delivery component 202 (FIG. 16B) to which tubular aortic component 12 (FIG. 16A) is attached (FIGs. 16A and 16C). Delivery component 202 includes control catheter 204 (FIG. 16B), about which tubular aortic component 12 (FIG. 16C) extends, nose cone 206 (FIGs. 16B and 16C) is fixed at a distal end of control catheter 204 (FIGs. 17A and 17B).
[0043] In one embodiment, shown in FIGs. 17A, 17B and 17C, delivery component 202 further includes inner sheath 210 extending about control catheter 204. A distal opening at distal end 214 of inner sheath 210, can be tucked into nose cone 206 (FIGs. 17A, 17B and 18). In still another embodiment, shown in FIGs. 19A and 19B, inner sheath 210 includes inferior portion 82, said inferior portion 82 having fluted portion 85 as can be seen in FIG. 20. Optionally, as can be seen in FIGs. 21A and 21B, inner sheath 210 can be tapered to narrow toward distal end 211 or of essentially constant diameter. In one embodiment, inner sheath 210 defines at least one through hole 280 at proximal end 282 of inner sheath 210, as shown in FIGs. 25A and 25B.
[0044] As can be seen in FIGs. 17A and 17B, introducer sheath 216 extends about inner sheath 210 and about tubular aortic component 12, wherein introducer sheath 216 is retractable relative to inner sheath 210 to thereby release distal end 214 of inner sheath 210. Nose cone 206 can thereafter be retracted within inner sheath 210.
[0045] Delivery component 202, shown in FIGs. 17A, 17B, 17C and 22, further includes at least one supporting wire 230 fixed at proximal end 224 to support base 235, substantially parallel to a major longitudinal axis of outer control tube 232 and free at the distal end 228, wherein free end 228 of at least one of supporting wire 230 and internal sutures 62 (FIG. 17B) at the proximal end 14 of tubular aortic component 12 releasably secures proximal end 14 of tubular aortic component 12 to at least one of supporting wires 230. Outer control tube 232 is slidable along control catheter 204. Supporting wires 230 are fixed at proximal ends 224 to support base 235 at outer control tube 232 distal to proximal apex clasp 240. Free ends 228 of support wires 230 are proximate to proximal end 14 and to nose cone 206. Proximal portion 252 of distal apex clasp 238 and outer control tube 232 are slidable along the control catheter 204 with movement of outer control tube 232 (FIGs. 16B and 22). Distal apex clasp 238 fixes proximal end 14 of tubular aortic component 12 by securing exposed apices 58 (FIG. 16C) of clasping stent 56 at proximal end 14 of tubular aortic component 12. As shown in FIG. 16B, distal portion 248 of distal apex clasp 238 mates with of teeth 252 of proximal portion 250 of distal apex clasp 238 in a closed position that secures exposed apices 58 of clasping stent 56 of tubular aortic component 12.
[0046] Proximal apex clasp 240 is at outer control tube 232 (FIG. 17B). Proximal apex clasp 240 includes teeth 246 (FIG. 16B) extending distally from proximal portion 244 of proximal clasp 240. Teeth 246 extend distally through retention component 78 of tubular aortic component 12, as shown in FIG. 17B.
[0047] As shown in FIGs. 23A-23D, tubular branch component 254 includes proximal end 256 and distal end 258, wherein proximal end 256 of tubular branch component 254 is configured to engage proximal end 30 of tunnel graft 28. In an embodiment, the engagement is by interfering relation between tubular branch component 254 and tunnel graft 28. When aortic graft assembly 10 is implanted in the aorta of a patient, a seal forms with at least one member of the group consisting of the proximal end of at least one of the tubular aortic component 12, tubular branch component 254 and second tubular branch component 260, and the distal end of at least one of tubular aortic component 12, tubular branch component 254 and second tubular component 260. A "seal" as defined herein, means that essentially no fluid will seep between the wall of a first conduit and the wall of a second conduit within which the first conduit is located. Such seals typically will be at the most proximal portion of a juncture between nested first and second conduits.
[0048] In one embodiment, supporting wire 230 has at least one stop 274 (FIG. 11), wherein stop 274 limits movement of suture loop 62 along supporting wire 230.
[0049] In another embodiment, tubular aortic component 12 includes radiopaque sutures 18 and inner sheath 210 includes radiopaque markers 276, all of which are longitudinally aligned along a path of relative movement of inner sheath 210 (FIGs. 16A-16F and 17A-17C) and tubular aortic component 12 during deployment of tubular aortic component 12, and are spaced apart from each other, whereby partial retraction of inner sheath 210 will cause overlap of radiopaque markers 276 with radiopaque markers 38. In one embodiment, radiopaque markers 38 are also, or alternatively, on superior portions of inner sheath 210 and tubular aortic component 12. Preferably, radiopaque markers 38, 276 are asymmetric, wherein a shape of radiopaque markers 38, 276 changes as radiopaque markers 38, 276 are aligned with a surgical site. Preferably, radiopaque markers 38, 276 of tubular aortic component 12 are elongated and are substantially aligned with the major longitudinal axis 24 of inner sheath 210.
[0050] In a preferred embodiment, referring back to FIGs. 16A-16F and 17A-17C, tubular aortic component 12 is further constrained at at least one end by a clasp, such as distal apex clasp 238 or proximal apex clasp 240, and the method includes the step of releasing the clasp with retraction of supporting wire 230 from suture loop 62 of tubular aortic component 12. In this embodiment, preferably, tubular aortic component 12 further includes at least one radiopaque marker 38, wherein, preferably, radiopaque marker 38 is located on tubular aortic component 12 facing away from cavity 284 (FIG. 18) of the curve 286 (FIG. 18) defined by control catheter 204. Preferably, inner sheath 210 further includes at least one radiopaque marker 276, wherein radiopaque marker 276 of inner sheath 210 overlaps at least one radiopaque marker 276 of tubular aortic component 12 when tubular aortic component 12 is partially deployed. In still another embodiment, tubular aortic component 12 is further constrained by proximal clasp 240 and proximal fixed end 234 of supporting wire 230.
[0051] A method for implanting a prosthesis includes the steps of delivering tubular aortic component 12 within introducer sheath 216 along guidewire 320 through an aorta 262 to aneurysm 270 of the patient, shown in FIGs. 24A-24E. Tubular aortic component 12 is radially constrained and supported at least in part by control catheter 204 (FIGs. 16B, 16C, 16D), which is slidable along guidewire 320 (FIGs. 24A-24E). As shown in FIGs. 16A-16F and 17A-17C, tubular aortic component 12 is further longitudinally constrained by at least one supporting wire 230 extending from support base 235 at outer control tube 232 extending about and slidable along control catheter 204. Free end 228 of at least one of supporting wire 230 is arcuate and extends through suture loop 62 (FIG. 17B), within proximal end 14 of tubular aortic component 12.
[0052] Referring back to FIGs. 24A-24E, tubular aortic component 12 is guided to aneurysm 270 along guidewire 320. Inner sheath 210 (FIG. 17B), is partially retracted from tubular aortic component 12, whereby supporting wire 230 at least partially restricts longitudinal movement of proximal end 14 of tubular aortic component 12 until proximal end 14 of tubular aortic component 12 is secure within aorta 262 (FIGs. 24A-24E) of the patient to thereby prevent collapse of proximal end 14 of tubular aortic component 12 at an inferior portion 264 of aorta 262.
[0053] In one embodiment, inner sheath 210 is releasably secured at distal end 214 within a cavity defined by the proximal end of nose cone 206 (FIG. 18). In this embodiment, as shown in FIGs. 24A-24E, optional inner sheath 210 is partially retracted to release the distal end of the inner sheath 210 from nose cone 206 and thereby cause partial expansion of tubular aortic component 12. Wall aperture 20 is aligned over at least one vessel ostium 290, 292, 294 at aneurysm site 263 of the patient. Optionally, in embodiments of the invention that employ inner sheath 210, inner sheath 210 is then partially retracted to expose the proximal end 14 of tubular aortic component 12, including crown stent 56 and the clasping stent 60 (FIG. 1A). Control tube 232 is then partially extended to release bare apices 58 (FIG. 1A) of clasping stent 56 from distal clasp 238 and to release retention component 78 from proximal clasp 240 (FIGs. 16B and 17B), while retaining suture loops 62 on ends 228 of supportwires 230 (FIGs.16A-16F and 17A-17C). Nose cone 206 is then partially retracted into proximal end of tubular aortic component 12 and the delivery assembly and tubular aortic component 12 are then advanced to a final position within aorta 262 spanning aneurysm 263 of the patient. Control tube 232 is then further retracted to release suture loops 62 from ends 228 of support wires 230. Inner sheath 210 is then fully retracted (in embodiments of the invention that employ inner sheath 210) and then nose cone 206 and supporting wires 230 are fully retracted to complete deployment of tubular aortic component 12.
[0054] There is described a method which includes the step of implanting at least one tubular branch component 254 in at least one of an innominate artery (also referred to as "brachiocephalic artery") 290, a left subclavian artery 292, a left common carotid artery 294, or right common carotid artery 296 of the patient into wall aperture 20 and tunnel graft 28 within tubular aortic component 12, as shown, with respect to the prior art, in FIGs. 13-15, and in FIGs. 24A-24E. The method may include the steps of implanting tubular branch component 254 into innominate artery 290, and another tubular branch component, into the left common carotid artery 294 (FIG. 24E).
[0055] Implantation of the aortic graft assemblies of the invention can include implantation in at least one of a portion of the ascending aorta, the aortic arch, the descending aorta and abdominal aorta (see FIGs. 12, 24A-24E and 26A-26C). Implantation near, around or at the arch of the aorta, can include a right common carotid to left common carotid artery bypass with ligation of the left common carotid inferior to the point of the bypass and a left common carotid artery to left subclavian artery bypass with ligation inferior to the bypass. In another embodiment, for example, an aortic graft assembly of the invention that includes two tubular branch components (e.g., one into the right common carotid, another into the left common carotid) can include a left common carotid artery to left subclavian artery bypass, with ligation of the left subclavian artery inferior to the bypass (see FIGs. 16 and 17). Alternatively, as shown in FIGs. 26A-26C, aortic assembly systems can be implanted in the abdominal aorta 300. Opening 84 can be placed in abdominal aorta proximate to celiac artery 302, superior mesenteric artery 304 or renal artery 306, thereby spanning aneurysm 308. Tubular branch component 254 can then be implanted into at least one of celiac artery 302, superior mesenteric artery 304 or at least one renal artery 306.
[0056] In another embodiment, shown in FIGs. 25A and 25B, inner sheath 210 about tubular aortic component 12, includes proximal perforated portion 280 that defines through-holes 282. Through-holes 282 can be defined by a mesh or fabric of perforation portion 280, as shown in FIG. 25A, or as distinct openings, such as longitudinal through-hole opening 284 shown in FIG. 25B. The through-holes permit relatively continuous blood flow during implantation of the prosthesis, as further described in U.S. Published Patent Application No.: 2010/0234932.
[0057] Suitable systems, delivery devices and components of systems, stent grafts as described in U.S. Application Nos. 11/449,337, filed on June 8, 2006; 11/699,700, filed on January 30, 2007; 11/700,609, filed on January 31, 2007; 11/701,867, filed on February 1, 2007; 11/828,653, filed on July 26, 2007; 12/137,592, filed on June 12, 2008; 11/701,876, filed on February 1, 2007; 61/164,545, filed on March 30, 2009; 12/459,387, filed on June 30, 2009; and U.S. Patent Nos.: 7,763,063; 8,007,605; 8,062,345; 8,062,349; 8,070,790; 8,292,943 and 8,308,790 can be employed to deliver the aortic graft assembly of the invention by the method described.
Example 1
[0058] A 74 year old male with penetrating atherosclerotic ulcer (PAU) of the aorta located on the interior side of the thoracic arch at the level of the left common carotid was treated. A model of the patient's anatomy was made based on computer tomography (CT) scanning. A right carotid to left carotid bypass was performed initially without ligating the left carotid. A tubular aortic component of an aortic graft assembly (46 mm-42 mm x 80 mm) was deployed at the sinotubular junction. The ascending aorta of this patent had a graft diameter of about 44 mm. A tubular aortic component having a diameter of 46/42 mm x80 mm was employed to provide a smaller healthy neck. The proximal end of the tubular aortic component of the aortic graft assembly was released to optimize apposition with the wall of the ascending aorta.
[0059] A tunnel graft (46 mm-34 mm x 220 mm) was used in the aortic graft assembly. The tunnel graft was 15 mm in diameter. The aperture of the tubular aortic component was 30 mm x 30 mm. A graft of a size of 15 mm - 17 mm x 100 mm or 15 mm - 17 mm x 110 mm) was employed to bridge the graft tunnel with the brachial cephalic trunk and a wire-catheter was positioned prior to implantation as a precautionary bailout. An angiogram was performed to confirm profusion to the and left common carotid arteries. The tunnel graft was advanced to the proximal portion of the aperture of the tubular aortic component with the distal end of at least one tubular branch component. The graft was aligned to allow canulation of the tunnel graft through the innominate or the left common carotid arteries based on movement of the tubular aortic component. The tunnel graft was canulated via the right common carotid. A relatively short tubular branch component was selected in this patient because the tunnel graft was deployed more distally. The distal end of the branch graft was aligned with the brachial cephalic trunk bifurcation and the tubular branch graft deployed without complication. An angiogram showed exclusion of the aneurysm with flow to the innominate artery and left common carotid artery via a carotid-carotid bypass.
Example 2
[0060] An 81 year old male with an aneurysm at the arch of the aorta was treated. A CT scan was employed to model the patient's anatomy. The thoracic aneurysm was in a region of the aortic arch and at least a portion of the descending aorta. The tunnel graft had a diameter of about 15 mm.
[0061] While this invention has been particularly shown and described with references to example embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.
a) a tubular aortic component (12) that defines a tunnel lumen and includes a proximal end (14) and a distal end (16) connected by a wall (18) of the tubular aortic component, the wall defining a wall aperture (20) that is between the proximal (14) and distal (16) ends, the wall aperture having a proximal end (22) and a distal end (26), the proximal end of the wall aperture extending perpendicular to a major longitudinal axis (24) of the tubular aortic component when viewed orthogonally to the major longitudinal axis;
b) a tunnel graft (28) connected to the wall of the tubular aortic component and extending from the wall aperture and within the tunnel lumen of the tubular aortic component toward the proximal end of the tubular aortic component, the tunnel graft having a proximal end (30) and a distal end (32), the distal end of the tunnel graft (28) being at the wall aperture of the tubular aortic component (12), the tunnel graft (28) further including
an open portion (84) at the wall aperture (20), the open portion (84) defining the distal end (32) of the tunnel graft; and
two tubular portions (100, 102) extending proximally from the proximal end of the open portion (84), the tubular portions (100, 102) each defining a proximal end (106) and a distal end (104) at the proximal end of the open portion (84);
c) a proximal stent (34) that supports the proximal end (14) of the tubular aortic component (12); and
d) a distal stent (36) that supports the distal end (16) of the tubular aortic component (12),
wherein the combined diameter at the distal ends (104) of the two tubular portions (100, 102) of the tunnel graft (28) at a point proximal to the proximal end (22) of the wall aperture (20) is smaller than the diameter of the proximal end (22) of the wall aperture (20).in which case optionally either:
a) wherein the clasping stent (56) is attached to an interior wall of the tubular
aortic component (12);
in which case further optionally wherein the tubular aortic component (12) includes
a centerline (160) that bisects the wall aperture (20) and two of the exposed proximal
apices (58) of the clasping stent (56) are adjacent to the centerline, whereby collapse
of the unattached apices (58) will cause at least partial collapse of the tubular
aortic component at the clasping stent (56); or
b) further including a crown stent (60) between the clasping stent (56) and the proximal end (14) of the tubular aortic component (12);
in which case further optionally wherein the crown stent includes proximal (59) and distal apices connected by struts;in which case further optionally wherein the proximal apices (59) of the crown stent are blunted relative to the distal apices of the crown stent;
in which case further optionally wherein the clasping (56) and crown (60) stents are nested with each other;
in which case further optionally wherein the crown stent is attached to an interior wall (76) of the tubular aortic component (12).
in which case optionally wherein at least one of the support wire sutures (62) is at an inferior portion (83) within the tubular aortic component (12);
in which case further optionally wherein the support wire sutures (62) are distal to proximal apices of the clasping stent;
in which case further optionally wherein the support wire sutures (62) are separated by at least one distal apex of the proximal clasping stent.
in which case optionally wherein:
a) the length of the proximal end of the wall aperture is about 6 mm, about 8 mm, about 10 mm, about 12 mm or about 14 mm; or
b) a longitudinal length of the wall aperture is equal to or less than about 90 mm; or
c) the longitudinal length of the wall aperture is equal to or greater than about 14 mm.
in which case optionally further including a radiopaque marker (38) at a distal apex (48) of the proximal stent (34).
in which case optionally:
a) the aortic graft assembly further including a radiopaque marker (38) at a proximal apex of the abutting distal stent; or
b) wherein the stents abutting the wall aperture abut the wall aperture at apices of the stents;
in which case further optionally further including a stent located between the proximal and distal ends of the wall aperture;in which case further optionally wherein the stent between the proximal and distal ends of the wall aperture includes struts that define at least a portion of the wall aperture.
in which case optionally wherein:
a) the retention component is at a proximal apex of the distal stent abutting the distal end of the wall aperture;
b) the retention component is a suture loop (62);
c) the retention component is at least one of a magnet or a stent apex; or
d) the retention component is radiopaque.
in which case optionally the polygon:
a) has four sides;
b) is a square;
c) is a rectangle;
d) is a parallelogram; or
e) is a rhombus.
in which case optionally wherein the tubular portions further include a stent at each of the proximal end and the distal end of each of the tubular portions;
in which case further optionally wherein the stents at the proximal and distal ends of the tubular portions include proximal and distal apices connected by struts;
in which case further optionally wherein at least one of the stent includes at least one barb (96);
in which case further optionally wherein the tubular portions further include at least one stent (98) between the stents (88, 90) at the proximal (92) and distal (94) ends of the tubular portions.
in which case further optionally at least one of the stents between the stents at the proximal and distal ends of the tubular portions includes at least one barb.
in which case further optionally wherein the stents of the tubular portions include nitinol.
in which case optionally wherein either:
a) the distal end of the tubular portions is generally conical; or
b) the tubular portions have a major longitudinal axis that is parallel to the major longitudinal axis of the tubular aortic component;
in which case further optionally wherein the proximal end of the tubular portions is either distal to the proximal end of the tubular aortic component; orcoterminous with the proximal end of the tubular aortic component.
in which case optionally wherein the angle is selected from the group consisting of ±10°, ±20°, ±30°, ±45°, ±90°, ±120°, ±135°, ±160°, ±170° and 180°.
in which case further optionally wherein one of the tubular portions is parallel to the other tubular portion;
in which case further optionally wherein the two tubular portions are each distinct and integrally complete tubular portions;
in which case further optionally wherein the tubular portions share a common wall of a first graft material (108) that partition a conduit of a second graft material (110), the first and second graft materials defining, at least in part, the tubular portions.
in which case optionally wherein the tunnel graft has a length in a range of between about 30 and about 50 mm;
in which case further optionally the proximal end of the tunnel graft is within at least about 5 mm, about 10 mm, about 15 mm or about 20 mm of the proximal end of the tubular aortic component.
a) a control catheter (204), about which the tubular aortic component extends; and
b) a nose cone (206) fixed at a distal end of the control catheter;
in which case optionally wherein the delivery component (202) further includes an inner sheath (210) extending about the control catheter (204) that defines a distal opening at a distal end of the inner sheath, wherein the nose cone is retractable within the inner sheath;in which case further optionally further including an introducer sheath (216) about the inner sheath and about the tubular aortic component, wherein the introducer sheath is retractable relative to the inner sheath to thereby release the distal end of the inner sheath, and whereby the nose cone can thereafter be retracted within the inner sheath;
in which case further optionally further including at least one supporting wire (230) fixed at a proximal end (224), substantially parallel to a major longitudinal axis of the control catheter and free at a distal end (228), wherein the free end (228) of at least one of the supporting wires (230) is arcuate, and further including internal sutures (62) at the proximal end (14) of the tubular aortic component (12) that releasably secure the proximal end (14) of the tubular aortic component (12) to at least one of the supporting wires (230);
in which case further optionally further including an outer control tube (232) slidable along the control catheter (204), wherein the at least one supporting wire (230) is fixed at the proximal end to the outer control tube;
in which case further optionally wherein the supporting wire is fixed at the proximal end to the outer control tube proximal to the nose cone and the free end is distal to the proximal end and is proximate to the nose cone;
in which case further optionally further including a distal apex clasp (238) at a distal end of the outer control tube and slidable along the control catheter with movement of the outer control tube;
in which case further optionally wherein the distal apex clasp fixes the proximal end of the tubular aortic component by securing the exposed apices of the clasping stent of the tubular aortic component;
in which case further optionally wherein the delivery component further includes a proximal apex clasp (240) at a proximal end of the outer control tube that includes a distal portion fixed to the control catheter and a proximal portion, the proximal portion including proximally extending teeth (252) that extend distally through the exposed apices of the clasping stent of the tubular aortic component;
in which case further optionally wherein the distal portion of the distal apex clasp includes a clasp sheath that overlays distal ends of the teeth of the distal apex clasp when in a closed position that secures exposed apices of the clasping stent of the tubular aortic component;
in which case further optionally wherein the proximally extending teeth of the proximal apex clasp secure the tubular aortic component at the retention component.
in which case optionally wherein the wall aperture has a diameter at least twice that of the widest diameter of the combined diameters of the at least one tubular branch component.
in which case further optionally wherein the wall aperture has a diameter at least three times that of the widest diameter of the combined diameters of the at least one tubular branch component.
a) further including at least one stent (64) between the proximal (34) and distal (36) stents wherein at least a portion of said stent includes alternating proximal and distal apices connected by struts (70); or
b) wherein the distal stent (36) is attached to an interior wall of the tubular aortic component (12); or
c) further including a circumferential stent (80) that surrounds the wall aperture (20); or
d) wherein the diameter of the proximal end (14) of the tubular aortic component (12) is greater than the diameter of the distal end (16) of the tubular aortic component (12); or
e) wherein an inferior portion (83) is on one side of the tubular aortic component (12) opposite the wall aperture (20) and is parallel to the major longitudinal axis (24) of the tubular aortic component (12), and a superior portion is on the opposite side of tubular aortic component, and wherein the inferior portion is fluted, whereby the diameter of the tubular aortic component increases from the distal end to the proximal end of the tubular aortic component; or
f) further including radiopaque markers (40) extending about the wall aperture (20) at the tubular aortic component (12).
g) further including at least one radiopaque marker at least one of the proximal end of the tunnel graft and the distal end of the tubular portion of the tunnel graft; or
h) wherein the proximal end of the tunnel graft has a diameter in a range of between about 5 mm and about 10 mm, between about 5 mm and about 15 mm or between about 8 mm and about 15 mm; or
i) in which the distance between a proximal end (22) of the wall aperture (20) and the proximal end (14) of the tubular aortic component (12) is in a range of between about 20 mm, about 40 mm, about 60 mm, about 80 mm or about 90 mm;
j) wherein the stents include nitinol;
k) further including a radiopaque marker at each of at least one of the proximal and distal ends of the tubular aortic component.
a) eine röhrenförmige Aortakomponente (12), die ein Tunnellumen definiert und ein proximales Ende (14) und ein distales Ende (16) enthält, die durch eine Wand (18) der röhrenförmigen Aortakomponente verbunden sind, wobei die Wand eine Wandöffnung (20) definiert, die zwischen dem proximalen (14) und dem distalen (16) Ende liegt, wobei die Wandöffnung ein proximales Ende (22) und ein distales Ende (26) aufweist, wobei das proximale Ende der Wandöffnung sich senkrecht zu einer Hauptlängsachse (24) der röhrenförmigen Aortakomponente erstreckt, wenn senkrecht zu der Hauptlängsachse betrachtet;
b) ein Tunneltransplantat (28), das mit der Wand der röhrenförmigen Aortakomponente verbunden ist und sich von der Wandöffnung aus und innerhalb des Tunnellumens der röhrenförmigen Aortakomponente hin zu dem proximalen Ende der röhrenförmigen Aortakomponente erstreckt, wobei das Tunneltransplantat ein proximales Ende (30) und ein distales Ende (32) aufweist, wobei das distale Ende des Tunneltransplantats (28) sich an der Wandöffnung der röhrenförmigen Aortakomponente (12) befindet, wobei das Tunneltransplantat (28) ferner Folgendes enthält:
einen offenen Abschnitt (84) an der Wandöffnung (20), wobei der offene Abschnitt (84) das distale Ende (32) des Tunneltransplantats definiert; und
zwei röhrenförmige Abschnitte (100, 102), die sich nach proximal von dem proximalen Ende des offenen Abschnitts (84) aus erstrecken, wobei die röhrenförmigen Abschnitte (100, 102) jeweils ein proximales Ende (106) und ein distales Ende (104) an dem proximalen Ende des offenen Abschnitts (84) definieren;
c) einen proximalen Stent (34), auf dem das proximale Ende (14) der röhrenförmigen Aortakomponente (12) gelagert ist; und
d) einen distalen Stent (36), auf dem das distale Ende (16) der röhrenförmigen Aortakomponente (12) gelagert ist,
wobei der kombinierte Durchmesser an den distalen Enden (104) der zwei röhrenförmigen Abschnitte (100, 102) des Tunneltransplantats (28) an einem Punkt proximal zum proximalen Ende (22) der Wandöffnung (20) kleiner ist als der Durchmesser des proximalen Endes (22) der Wandöffnung (20).in welchem Fall optional entweder:
a) wobei der Spannstent (56) an einer Innenwand der tubulären Aorten-Komponente (12)
angebracht ist;
in welchem Fall ferner optional, wobei die tubuläre Aorten-Komponente (12) eine Mittellinie
(160) umfasst, die die Wandöffnung (20) halbiert und zwei der freiliegenden proximalen
Spitzen (58) des Spannstents (56) neben der Mittellinie sind, wodurch der Zusammenbruch
der ungebunden Spitzen (58) mindestens teilweise zum Zusammenbruch der tubulären Aorten-Komponente
am Spannstent (56) führen wird; oder
b) ferner umfassend einen Kronen-Stent (60) zwischen dem Spannstent (56) und dem proximalen Ende (14) der tubulären Aorten-Komponente (12);
in welchem Fall ferner optional, wobei der Kronen-Stent proximale (59) und distale Spitzen umfasst, die durch Streben verbunden sind;in welchem Fall ferner optional, wobei die proximalen Spitzen (59) des Kronen-Stents relativ zu den distalen Spitzen des Kronen-Stents abgestumpft sind;
in welchem Fall ferner optional, wobei der Spann- (56) und Kronen-Stent (60) ineinander verschachtelt sind;
in welchem Fall ferner optional, wobei der Kronen-Stent an einer Innenwand (76) der tubulären Aorten-Komponente (12) angebracht ist.
in welchem Fall ferner optional, wobei die Stützdrahtnähte (62) distal zu proximalen Spitzen des Spannstents sind;
in welchem Fall ferner optional, wobei die Stützdrahtnähte (62) durch mindestens eine distale Spitze des proximalen Spannstents getrennt sind.
a) die Länge des proximalen Endes der Wandöffnung etwa 6 mm, etwa 8 mm, etwa 10 mm, etwa 12 mm oder etwa 14 mm ist; oder
b) eine Längslänge der Wandöffnung gleich oder kleiner als etwa 90 mm ist; oder
c) die Längslänge der Wandöffnung gleich oder größer als etwa 14 mm ist; oder
in welchem Fall optional ferner umfassend eine strahlenundurchlässige Markierung (38) an einer distalen Spitze (48) des proximalen Stents (34).
in welchem Fall optional:
a) die Aorten-Transplantatseinheit ferner umfasst eine strahlenundurchlässige Markierung (38) an einer proximalen Spitze des anstoßenden distalen Stents; oder
b) wobei die Stents, die die Wandöffnung anstoßen, die Wandöffnung an den Spitzen der Stents anstoßen;
in welchem Fall ferner optional ferner umfassend einen Stent, der zwischen den proximalen und distalen Enden der Wandöffnung angeordnet ist;in welchem Fall ferner optional, wobei der Stent zwischen den proximalen und distalen Enden der Wandöffnung Streben umfasst, die mindestens einen Abschnitt der Wandöffnung definieren.
in welchem Fall optional, wobei:
a) die Rückhaltekomponente an einer proximalen Spitze des distalen Stents ist, der das distale Ende der Wandöffnung anstößt;
b) die Rückhaltekomponente eine Nahtschlaufe (62) ist;
c) die Rückhaltekomponente mindestens eine von einem Magneten oder einer Stentspitze ist; oder
d) die Rückhaltekomponente strahlenundurchlässig ist.
in welchem Fall optional das Polygon:
a) hat vier Seiten;
b) ist ein Quadrat;
c) ist ein Rechteck;
d) ist ein Parallelogramm; oder
e) ist ein Rhombus.
in welchem Fall optional, wobei die tubulären Abschnitte ferner einen Stent an jedem des proximalen Endes und distalen Endes von jedem der tubulären Abschnitte umfasst;
in welchem Fall ferner optional, wobei die Stents an den proximalen und distalen Enden der tubulären Abschnitte proximale und distale Spitzen umfassen, die durch Streben verbunden sind;
in welchem Fall ferner optional, wobei mindestens einer der Stents mindestens einen Widerhaken (96) umfasst;
in welchem Fall ferner optional, wobei die tubulären Abschnitte ferner mindestens einen Stent (98) zwischen den Stents (88, 90) an den proximalen (92) und distalen (94) Enden der tubulären Abschnitte umfassen;
in welchem Fall ferner optional umfasst mindestens einer der Stents zwischen den Stents an den proximalen und distalen Enden der tubulären Abschnitte mindestens einen Widerhaken;
in welchem Fall ferner optional, wobei die Stents der tubulären Abschnitte Nitinol umfassen.
in welchem Fall optional, wobei entweder:
a) das distale Ende der tubulären Abschnitte im Allgemeinen konisch ist; oder
b) die tubulären Abschnitte eine Hauptlängsachse aufweisen, die parallel zur Hauptlängsachse der tubulären Aorten-Komponente ist;
in welchem Fall ferner optional, wobei das proximale Ende der tubulären Abschnitte entweder distal zum proximalen Ende der tubulären Aorten-Komponente ist; oderan das proximale Ende der tubulären Aorten-Komponente angrenzend ist.
in welchem Fall optional, wobei der Winkel aus der Gruppe ausgewählt ist, die aus ±10°, ±20°, ±30°, ±45°, ±90°, ±120°, ±135°, ±160°, ±170° und 180° besteht.
in welchem Fall ferner optional, wobei einer der tubulären Abschnitte parallel zum anderen tubulären Abschnitt ist;
in welchem Fall ferner optional, wobei die zwei tubulären Abschnitte jeweils verschiedene und integral vollständige tubuläre Abschnitte sind;
in welchem Fall ferner optional, wobei die tubulären Abschnitte eine gemeinsame Wand eines ersten Transplantatmaterials (108) teilen, die eine Leitung eines zweiten Transplantatmaterials (110) trennt, die ersten und die zweiten Transplantatmaterialien definieren, mindestens teilweise, die tubulären Abschnitte.
in welchem Fall ferner optional, wobei das getunnelte Transplantat eine Länge in einem Bereich zwischen etwa 30 und etwa 50 mm aufweist;
in welchem Fall ferner optional ist das proximale Ende des getunnelten Transplantats innerhalb mindestens etwa 5 mm, etwa 10 mm, etwa 15 mm oder etwa 20 mm des proximalen Endes der tubulären Aorten-Komponente.
a) einen Steuerkatheter (204), um den die tubuläre Aorten-Komponente sich erstreckt;
und
b) einen Nasenkonus (206), der an einem distalen Ende des Steuerkatheters befestigt ist;
in welchem Fall optional, wobei die Förderkomponente (202) ferner eine innere Hülle (210) umfasst, die sich um den Steuerkatheter (204) erstreckt, der eine distale Öffnung an einem distalen Ende der inneren Hülle definiert, wobei der Nasenkonus innerhalb der inneren Hülle versenkbar ist;in welchem Fall ferner optional ferner umfassend eine Einführungshülle (216) um die innere Hülle und um die tubuläre Aorten-Komponente, wobei die Einführungshülle versenkbar relativ zur inneren Hülle ist, um hierdurch das distale Ende der inneren Hülle freizugeben, und wodurch der Nasenkonus danach innerhalb der inneren Hülle zurückgezogen werden kann;
in welchem Fall optional ferner umfassend mindestens einen Stützdraht (230), der an einem proximalen Ende (224) befestigt ist, der im Wesentlichen parallel zu einer Hauptlängsachse des Steuerkatheters und frei an einem distalen Ende (228) ist, wobei das freie Ende (228) von mindestens einem der Stützdrähte (230) gebogen ist, und ferner umfassend innere Nähte (62) am proximalen Ende (14) der tubulären Aorten-Komponente (12), die lösbar das proximale Ende (14) der tubulären Aorten-Komponente (12) an mindestens einem der Stützdrähte (230) sichert;
in welchem Fall ferner optional ferner umfassend ein äußeres Steuerrohr (232) verschiebbar längs des Steuerkatheters (204), wobei der mindestens eine Stützdraht (230) am proximalen Ende mit dem äußeren Steuerrohr befestigt ist;
in welchem Fall ferner optional, wobei der Stützdraht am proximalen Ende mit dem äußeren Steuerrohr proximal zum Nasenkonus befestigt ist und das freie Ende distal zum proximalen Ende ist und nahe des Nasenkonus ist;
in welchem Fall ferner optional ferner umfassend einen distalen Spitzenverschluss (238) an einem distalen Ende des äußeren Steuerrohrs und verschiebbar entlang des Steuerkatheters mit der Bewegung des äußeren Steuerrohrs;
in welchem Fall ferner optional, wobei der distale Spitzenverschluss das proximale Ende der tubulären Aorten-Komponente befestigt, indem er die freiliegenden Spitzen des Spannstents der tubulären Aorten-Komponente sichert;
in welchem Fall ferner optional, wobei die Förderkomponente ferner einen proximalen Spitzenverschluss (240) an einem proximalen Ende des äußeren Steuerrohrs umfasst, das einen distalen Abschnitt umfasst, der am Steuerkatheter und einem proximalen Abschnitt befestigt ist, wobei der proximale Abschnitt proximal sich erstreckende Zähne (252) umfasst, die sich in distaler Richtung durch die freiliegenden Spitzen des Spannstents der tubulären Aorten-Komponente erstrecken;
in welchem Fall ferner optional, wobei der distale Abschnitt des distalen Spitzenverschlusses eine Schnapphülle umfasst, die sich der distalen Enden der Zähne des distalen Spitzenverschlusses überlagert, wenn sie in einer geschlossenen Position ist, die freiliegende Spitzen des Spannstents der tubulären Aorten-Komponente sichert;
in welchem Fall ferner optional, wobei die sich proximal erstreckenden Zähne des proximalen Spitzenverschlusses die tubuläre Aorten-Komponente am Rückhaltekomponente sichert.
in welchem Fall optional, wobei die Wandöffnung einen Durchmesser mindestens das Doppelte des größten Durchmessers der kombinierten Durchmesser von mindestens einer tubulären verzweigten Komponente aufweist;
in welchem Fall ferner optional, wobei die Wandöffnung einen Durchmesser mindestens das Dreifache des größten Durchmessers der kombinierten Durchmesser von mindestens einer tubulären verzweigten Komponente aufweist.
a) ferner umfassend mindestens einen Stent (64) zwischen den proximalen (34) und distalen (36) Stents, wobei mindestens ein Abschnitt des genannten Stents alternierende proximale und distale Spitzen umfasst, die durch Streben (70) verbunden sind; oder
b) wobei der distale Stent (36) an einer Innenwand der tubulären Aorten-Komponente (12) angebracht ist; oder
c) ferner umfassend einen umlaufenden Stent (80), der die Wandöffnung (20) umgibt; oder
d) wobei der Durchmesser des proximalen Endes (14) der tubulären Aorten-Komponente (12) größer als der Durchmesser des distalen Endes (16) der tubulären Aorten-Komponente (12) ist; oder
e) wobei ein unterer Abschnitt (83) auf einer Seite der tubulären Aorten-Komponente (12) gegenüber der Wandöffnung (20) ist und parallel zur Hauptlängsachse (24) der tubulären Aorten-Komponente (12) ist und ein oberer Abschnitt auf der gegenüberliegenden Seite der tubulären Aorten-Komponente ist, wobei der untere Abschnitt gerillt ist, wodurch der Durchmesser der tubulären Aorten-Komponente sich vom distalen Ende zum proximalen Ende der tubulären Aorten-Komponente erhöht; oder
f) ferner umfassend strahlungsundurchlässige Markierungen (40), die sich um die Wandöffnung (20) an der tubulären Aorten-Komponente (12) erstrecken;
g) ferner umfassend mindestens eine strahlungsundurchlässige Markierung mindestens eines des proximalen Endes des getunnelten Transplantats und des distalen Endes des tubulären Abschnitts des getunnelten Transplantats; oder
h) wobei das proximale Ende des getunnelten Transplantats einen Durchmesser in einem Bereich von zwischen etwa 5 mm und etwa 10 mm, zwischen etwa 5 mm und etwa 15 mm oder zwischen etwa 8 mm und etwa 15 mm aufweist; oder
i) in dem der Abstand zwischen einem proximalen Ende (22) der Wandöffnung (20) und dem proximalen Ende (14) der tubulären Aorten-Komponente (12) in einem Bereich von zwischen etwa 20 mm, etwa 40 mm, etwa 60 mm, etwa 80 mm oder etwa 90 mm ist;
j) wobei die Stents Nitinol umfassen;
k) ferner umfassend eine strahlenundurchlässige Markierung an jeder von mindestens einem der proximalen und distalen Enden der tubulären Aorten-Komponente.
a) un composant aortique tubulaire (12) qui définit une lumière de tunnel et inclut
une extrémité proximale (14) et une extrémité distale (16) raccordées par une paroi
(18) du composant aortique tubulaire, la paroi définissant une ouverture de paroi
(20) qui est située entre les extrémités proximale (14) et
distale (16), l'ouverture de paroi ayant une extrémité proximale (22) et une extrémité
distale (26), l'extrémité proximale de l'ouverture de paroi s'étendant perpendiculairement
à un grand axe longitudinal (24) du composant aortique tubulaire en vue orthogonale
au grand axe longitudinal ;
b) une greffe de tunnel (28) raccordée à la paroi du composant aortique tubulaire
et s'étendant depuis l'ouverture de paroi et au sein de la lumière de tunnel du composant
aortique tubulaire vers l'extrémité proximale du composant aortique tubulaire, la
greffe de tunnel ayant une extrémité proximale (30) et une extrémité distale (32),
l'extrémité distale de la greffe de tunnel (28) étant au niveau de l'ouverture de
paroi du composant aortique tubulaire (12), la greffe de tunnel (28) incluant en outre
une portion ouverte (84) au niveau de l'ouverture de paroi (20), la portion ouverte
(84) définissant l'extrémité distale (32) de la greffe de tunnel ; et
deux portions tubulaires (100, 102) s'étendant proximalement depuis l'extrémité proximale
de la portion ouverte (84), les portions tubulaires (100, 102) définissant chacune
une extrémité proximale (106) et une extrémité distale (104) au niveau de l'extrémité
proximale de la portion ouverte (84) ;
c) un stent proximal (34) qui supporte l'extrémité proximale (14) du composant aortique tubulaire (12) ; et
d) un stent distal (36) qui supporte l'extrémité distale (16) du composant aortique tubulaire (12),
dans lequel le diamètre combiné au niveau des extrémités distales (104) des deux portions tubulaires (100, 102) de la greffe de tunnel (28) en un point proximal à l'extrémité proximale (22) de l'ouverture de paroi (20) est plus petit que le diamètre de l'extrémité proximale (22) de l'ouverture de paroi (20).a) dans lequel le stent d'accrochage (56) est fixé à une paroi intérieure du composant
aortique tubulaire (12) ;
auquel cas, éventuellement encore, dans lequel le composant aortique tubulaire (12)
inclut un axe médian (160), qui divise en deux l'ouverture de paroi, (20) et deux
des sommets proximaux exposés (58) du stent d'accrochage (56) sont adjacents à l'axe
médian, par lequel l'effondrement des sommets non fixés (58) provoquera au moins l'effondrement
partiel du composant aortique tubulaire au niveau du stent d'accrochage (56) ; ou
b) incluant de plus un stent à couronne (60) entre le stent d'accrochage (56) et l'extrémité proximale (14) du composant aortique tubulaire (12) ;
auquel cas, éventuellement encore, dans lequel le stent à couronne inclut des sommets proximaux (59) et distaux reliés par des entretoises ;auquel cas, éventuellement encore, dans lequel les sommets proximaux (59) du stent à couronne sont émoussés par rapport aux sommets distaux du stent à couronne ;
auquel cas, éventuellement encore, dans lequel les stents d'accrochage (56) et à couronne (60) sont imbriqués l'un dans l'autre ;
auquel cas, éventuellement encore, dans lequel le stent à couronne est fixé à une
paroi intérieure (76) du composant aortique tubulaire (12).
auquel cas, éventuellement, dans lequel au moins l'une des sutures par fil de support (62) se trouve au niveau d'une section inférieure (83) à l'intérieur du composant aortique tubulaire (12) ;
auquel cas, éventuellement encore, dans lequel les sutures par fil de support (62) sont distales par rapport aux sommets proximaux du stent d'accrochage ; auquel cas, éventuellement encore, dans lequel les sutures par fil de support (62) sont
séparées par au moins un sommet distal du stent d'accrochage proximal.
a) la longueur de l'extrémité proximale de l'ouverture de paroi est d'environ 6 mm, d'environ 8 mm, d'environ 10 mm, d'environ 12 mm ou d'environ 14 mm ; ou
b) une longueur longitudinale de l'ouverture de paroi est inférieure ou égale à environ 90 mm ; ou
c) la longueur longitudinale de l'ouverture de paroi est supérieure ou égale à environ 14 mm.
auquel cas, éventuellement encore, incluant un marqueur radio-opaque (38) à un sommet distal (48) du stent proximal (34).
auquel cas, éventuellement :
a) l'ensemble de greffe aortique incluant de plus un marqueur radio-opaque (38) à
un
sommet proximal du stent distal en butée ; ou
b) dans lequel les stents venant buter contre l'ouverture de paroi viennent buter contre l'ouverture de paroi aux sommets des stents ;
auquel cas, éventuellement encore, incluant de plus un stent situé entre les extrémités proximale et distale de l'ouverture de paroi ;auquel cas, éventuellement encore, dans lequel le stent entre les extrémités proximale et distale de l'ouverture de paroi inclut des entretoises définissant au moins une section de l'ouverture de paroi.
auquel cas, éventuellement, dans lequel :
a) le composant de retenue se situe à un sommet proximal du stent distal venant buter contre l'extrémité distale de l'ouverture de paroi ;
b) le composant de retenue est une boucle de suture (62) ;
c) le composant de retenue est au moins un sommet d'un aimant ou d'un stent ; ou
d) le composant de retenue est radio-opaque.
auquel cas, éventuellement, le polygone :
a) comporte quatre côtés ;
b) est un carré ;
c) est un rectangle ;
d) est un parallélogramme ; ou
e) est un losange.
auquel cas, éventuellement, dans lequel les sections tubulaires incluent de plus un stent à chaque extrémité proximale et distale de chacune des sections tubulaires ;
auquel cas, éventuellement encore, dans lequel les stents aux extrémités proximale et distale des sections tubulaires incluent des sommets proximaux et distaux reliés par des entretoises ;
auquel cas, éventuellement encore, dans lequel au moins une des stents inclut au moins une barbelure (96) ; auquel cas, éventuellement encore, dans lequel les sections tubulaires incluent de plus au moins un stent (98) entre les stents (88, 90) aux extrémités proximale (92) et distale (94) des sections tubulaires ;
auquel cas, éventuellement encore, au moins un des stents entre les stents aux extrémités proximale et distale des sections tubulaires inclut au moins une barbelure ;
auquel cas, éventuellement encore, dans lequel les stents des sections tubulaires
incluent du nitinol.
auquel cas, éventuellement, dans lequel soit :
a) l'extrémité distale des sections tubulaires est généralement conique ; ou
b) les sections tubulaires possèdent un axe longitudinal principal étant parallèle à l'axe longitudinal principal du composant aortique tubulaire ;
auquel cas, éventuellement encore, dans lequel l'extrémité proximale des sections tubulaires est soit distale par rapport à l'extrémité proximale du composant aortique tubulaire oucontiguë à l'extrémité proximale du composant aortique tubulaire.
auquel cas, éventuellement, dans lequel l'angle est choisi dans un groupe constitué par des angles de ± 10°, ± 20°, ± 30°, ± 45°, ± 90°, ± 120°, ± 135°, ± 160°, ± 170° et 180°.
auquel cas, éventuellement encore, dans lequel l'une des sections tubulaires est parallèle à l'autre section tubulaire ;
auquel cas, éventuellement encore, dans lequel les deux sections tubulaires sont chacune distinctes et terminent intégralement les sections tubulaires ; auquel cas, éventuellement encore, dans lequel les sections tubulaires disposent d'une paroi commune d'un premier matériau de greffe (108) qui partage un conduit d'un second matériau de greffe (110), les premier et second matériaux de greffe définissant, au moins en partie, les sections tubulaires.
auquel cas, éventuellement encore, l'extrémité proximale de la greffe de tunnel se trouve à l'intérieur d'au moins 5 mm environ, 10 mm environ, 15 mm environ ou 20 mm environ de l'extrémité proximale du composant aortique tubulaire.
a) un cathéter de contrôle (204) autour duquel le composant aortique tubulaire se
prolonge ;
et
b) une pointe en forme d'ogive (206) fixée à une extrémité distale du cathéter de contrôle ;
auquel cas, éventuellement, dans lequel le composant de distribution (202) inclut de plus une gaine intérieure (210) se prolongeant autour du cathéter de contrôle (204) qui définit une ouverture distale à l'extrémité distale de la gaine intérieure, dans lequel la pointe en forme d'ogive peut se rétracter à l'intérieur de la gaine intérieure ;auquel cas, éventuellement encore, incluant de plus une gaine d'introduction (216) autour de la gaine intérieure et autour du composant aortique tubulaire, dans lequel la gaine d'introduction peut se rétracter par rapport à la gaine intérieure pour ainsi relâcher l'extrémité distale de la gaine intérieure, et par laquelle la pointe en forme d'ogive peut, par la suite, se rétracter à l'intérieur de la gaine intérieure ; auquel cas, éventuellement encore, incluant de plus au moins un câble de support (230), fixé à une extrémité proximale (224), substantiellement parallèle à un axe longitudinal principal du cathéter de contrôle et libre à une extrémité distale (228), dans lequel l'extrémité libre (228) d'au moins un des câbles de support (230) est arquée, et incluant de plus des sutures internes (62) à l'extrémité proximale (14) du composant aortique tubulaire (12) qui fixent de manière amovible l'extrémité proximale (14) du composant aortique tubulaire (12) à l'au moins un des câbles de support (230) ;
auquel cas, éventuellement encore, incluant de plus un tube de commande extérieur (232) pouvant coulisser le long du cathéter de contrôle (204), dans lequel l'au moins un câble de support (230) est fixé à l'extrémité proximale au tube de commande extérieur ;
auquel cas, éventuellement encore, dans lequel le câble de support est fixé à l'extrémité proximale au tube de commande extérieur proximal à la pointe en forme d'ogive et l'extrémité libre est distale par rapport à l'extrémité proximale et est proche de la pointe en forme d'ogive ;
auquel cas, éventuellement encore, incluant de plus un crochet à sommet distal (238) à une extrémité distale du tube de commande extérieur et pouvant coulisser le long du cathéter de contrôle grâce au mouvement du tube de commande extérieur ;
auquel cas, éventuellement encore, dans lequel le crochet à sommet distal fixe l'extrémité proximale du composant aortique tubulaire en fixant les sommets exposés du stent d'accrochage du composant aortique tubulaire ;
auquel cas, éventuellement encore, dans lequel le composant de distribution inclut de plus un crochet à sommet proximal (240) à une extrémité proximale du tube de commande extérieur incluant un section distale fixée au cathéter de contrôle et à une section proximale, la section proximale incluant des dents d'extension (252) en position proximale qui s'étendent de façon distale par l'intermédiaire des sommets exposés du stent d'accrochage du composant aortique tubulaire ;
auquel cas, éventuellement encore, dans lequel la section distale du crochet à sommet distal inclut une gaine à crochet se superposant sur les extrémités distales des dents du crochet à sommet distal, lorsqu'elle se trouve dans une position de fermeture, qui fixe les sommets exposés du stent d'accrochage du composant aortique tubulaire ;
auquel cas, éventuellement encore, dans lequel les dents d'extension en position proximale du crochet à sommet proximal fixent le composant aortique tubulaire au composant de retenue.
auquel cas, éventuellement, dans lequel l'ouverture de paroi possède un diamètre d'au moins deux fois le diamètre le plus large des diamètres combinés de l'au moins un composant de branche tubulaire ;
auquel cas, éventuellement encore, dans lequel l'ouverture de paroi possède un diamètre d'au moins trois fois le diamètre le plus large des diamètres combinés de l'au moins un composant de branche tubulaire.
a) incluant de plus au moins un stent (64) entre les stents proximaux (34) et distaux (36) dans lequel au moins une section dudit stent inclut des sommets proximaux et distaux alternés reliés par des entretoises (70) ; ou
b) dans lequel le stent distal (36) est fixé à une paroi intérieure du composant aortique tubulaire (12) ; ou
c) incluant de plus un stent concentrique (80) entourant l'ouverture de paroi (20) ; ou
d) dans lequel le diamètre de l'extrémité proximale (14) du composant aortique tubulaire (12) est supérieur au diamètre de l'extrémité distale (16) du composant aortique tubulaire (12) ; ou
e) dans lequel une section inférieure (83) se trouve sur un côté du composant aortique tubulaire (12) opposé à l'ouverture de paroi (20) et est parallèle à l'axe longitudinal principal (24) du composant aortique tubulaire (12), et une section supérieure se trouve sur le côté opposé du composant aortique tubulaire, et dans lequel la section inférieure est cannelée, par lesquelles le diamètre du composant aortique tubulaire augmente de l'extrémité distale à l'extrémité proximale du composant aortique tubulaire ; ou
f) incluant de plus des marqueurs radio-opaques (40) se prolongeant autour de l'ouverture de paroi (20) au niveau du composant aortique tubulaire (12) ;
g) incluant de plus au moins un marqueur radio-opaque au moins une de l'extrémité proximale de la greffe de tunnel et de l'extrémité distale de la section tubulaire de la greffe de tunnel ; ou
h) dans lequel l'extrémité proximale de la greffe de tunnel possède un diamètre compris entre environ 5 mm et environ 10 mm, entre environ 5 mm et environ 15 mm ou entre environ 8 mm et environ 15 mm ; ou
i) dans lequel la distance entre une extrémité proximale (22) de l'ouverture de paroi (20) et l'extrémité proximale (14) du composant aortique tubulaire (12) est égale à environ 20 mm, environ 40 mm, environ 60 mm, environ 80 mm ou environ 90 mm ;
j) dans lequel les stents incluent du nitinol ;
k) incluant de plus un marqueur radio-opaque à chacune de l'au moins une des extrémités proximale et distale du composant aortique tubulaire.
REFERENCES CITED IN THE DESCRIPTION
This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.
Patent documents cited in the description
- US2011087318A1 [0002]
- US8062345B [0023] [0027] [0057]
- US20100030255A [0023]
- US7763063B [0027] [0057]
- US20100234932A [0056]
- US11449337B [0057]
- US11699700B [0057]
- US11700609B [0057]
- US11701867B [0057]
- US11828653B [0057]
- US12137592B [0057]
- US11701876B [0057]
- US61164545B [0057]
- US12459387B [0057]
- US8007605B [0057]
- US8062349B [0057]
- US8070790B [0057]
- US8292943B [0057]
- US8308790B [0057]